Hands-on training for SDTM conversion

March 10, 2010 – 10:50 am by Colette Pilkus

With FDA’s adoption of a standardized data file format for clinical data submissions, clinical researchers need to know these new standards when collecting and preparing their clinical trial data for submission, since it is the only way that clinical data can be submitted. The ultimate purpose of using the Study Data Tabulation Model (SDTM) is [...]

Tags: Clinical Data Interchange Standards Consortium, Clinical Trials & Surveys Corp., FDA, Study Data Tabulation Model

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BMS investor day

March 4, 2010 – 9:31 am by Michael Christel

You can follow us this afternoon on Twitter, where I’ll be reporting live from the Bristol-Myers Squibb investor meeting in New York City. Fresh off news of his retirement, CEO Jim Cornelius will provide opening remarks. His successor, Lamberto Andreotti, will then present an overview of the company and its plans moving forward. The rest of the [...]

Tags: Bristol-Myers Squibb

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Dual-filing feat a rarity for little guy

February 17, 2010 – 2:18 pm by Michael Christel

You may have read recently about a small biotech outfit in New Jersey having successfully submitted simultaneous regulatory filings in the United States and Europe for Luveniq, a new oral treatment for non-infectious uveitis, an inflammatory condition of the eye that can lead to blindness. You may have also wondered how a company of this size – in this case, Lux Biosciences and its staff of 22 – was able to pull off such a feat. [...]

Tags: biotechnology, eye disease, Luveniq, regulatory

Posted in Uncategorized, clinical trials, filed for approval | No Comments »

MicroRNAs may revolutionize NSCLC classification

February 3, 2010 – 11:54 am by Colette Pilkus

Routine histophathology is the gold standard method of non-small cell lung cancer classification, but this method is considered unreliable, with poor reproducibility and low observer correlation. Studies show that when given the same sample, pathologists will disagree on the diagnosis in 30% to 40% of cases in classifying non-small cell lung squamous samples. Studies have [...]

Tags: microRNAs, miRview, NSCLC, Rosetta Genomics

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Quintiles stakes out “new health” territory

January 26, 2010 – 2:12 pm by Chris

Quintiles, the huge biopharmaceutical services company, made the announcement that it has shifted its positioning and brand identity to something called “Navigating the New Health.” There’s even a new logo (look left). The rounded “Q” seems to imply the full circle of services that Quintiles provides (at least, that is my guess).
“The Quintiles name now [...]

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Q&A: Steve Paul

January 25, 2010 – 10:34 am by Michael Christel

Click ahead for a recent discussion I had with Lilly R&D leader Steve Paul, who is retiring from the company on Feb. 28. We touched on several topics, including the evolution of Lilly’s pipeline under Dr. Paul’s watch; new R&D leadership at the company; the industry’s responsibility to sustain innovation; NIH funding; and the future for the former neuroscientist-turned-executive. [...]

Tags: Eli Lilly

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Charles River’s preclinical site suspension to cost 300 jobs

January 11, 2010 – 7:35 pm by Michael Christel

Charles River Laboratories International Inc. has provided additional details regarding today’s announcement that the company is suspending operations at its Shrewsbury, Mass., preclinical site in the middle of the year. According to the world’s third-ranked publicly traded CRO, 300 people will be laid off as a result of the move. Said Charles River CEO James C. Foster, in a statement emailed by the company late this afternoon: “This decision comes after a challenging year in which the consolidation of the biopharmaceutical industry, the slowdown in R&D efforts, and financial constraints for biotechnology companies resulted in [...]

Tags: Charles River, CRO, preclinical

Posted in CRO | 1 Comment »

Closer peek at Novartis-Alcon potential

January 6, 2010 – 1:27 pm by Michael Christel

Not surprisingly, moods are turning a tad testy in Novartis’ bid to gain full control of Swiss neighbor Alcon Inc. But talk of “coercive’’ tactics, minority shareholder protection, and independent director committees aside, just how visionary the potential eye-care deal really is appears a bit unclear. [...]

Tags: Alcon, eye disease, Lucentis, Novartis

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StudyOptimizer gets patient enrollment programs back on track

December 11, 2009 – 4:27 pm by Colette Pilkus

Bringing a drug to market in a timely fashion is difficult and one of the biggest challenges facing pharmaceutical companies. Due to patent expirations, shrinking drug pipelines, and the financial crisis on Wall Street, manufacturers are being forced to speed up the drug-delivery process to bring drugs to market and capitalize on the revenue. Companies [...]

Tags: clinical trials, DecisionView, IDC, StudyOptimizer

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Emerging markets push has CRO at ready

December 2, 2009 – 5:53 pm by Michael Christel

A common theme echoed by big pharma these days, particularly during the recent blitz of third-quarter earnings releases, is a renewed focus on emerging markets. As a result, global-minded CROs, many dealing with R&D slowdowns in developed markets, have had to respond to soaring demand for clinical development services in areas like Asia Pacific, Latin America, and parts of Europe. One such company is Pennsylvania-based ReSearch Pharmaceutical Services Inc. (RPS), which just this week completed its global platform for outsourced clinical trials across four continents. [...]

Tags: China, emerging markets, outsourcing, RPS

Posted in CRO, Uncategorized, clinical trials | No Comments »